Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-01-01 @ 1:32 PM
Study NCT ID:
NCT01508195
Status:
COMPLETED
Last Update Posted:
2013-01-31
First Post:
2012-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Canagliflozin and Metformin Immediate Release (50 mg/500 mg) FDC Tablets in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068896', 'term': 'Canagliflozin'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-30', 'studyFirstSubmitDate': '2012-01-09', 'studyFirstSubmitQcDate': '2012-01-09', 'lastUpdatePostDateStruct': {'date': '2013-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Canagliflozin plasma concentrations', 'timeFrame': 'Up to 72 hours in Treatment Period 1 and Treatment Period 2'}, {'measure': 'Metformin plasma concentrations', 'timeFrame': 'Up to 24 hours in Treatment Period 1 and Treatment Period 2'}], 'secondaryOutcomes': [{'measure': 'Changes in clinical laboratory test values', 'timeFrame': 'Up to approximately 51 days (includes from time of screening through study completion including the washout interval)'}, {'measure': 'Changes in vital signs measurements', 'timeFrame': 'Up to approximately 51 days (includes from time of screening through study completion including the washout interval)'}, {'measure': 'Changes in electrocardiogram (ECG) parameters', 'timeFrame': 'Up to approximately 51 days (includes from time of screening through study completion including the washout interval)'}, {'measure': 'Changes in physical examination results', 'timeFrame': 'Up to approximately 51 days (includes from time of screening through study completion including the washout interval)'}, {'measure': 'The number of patients reporting adverse events', 'timeFrame': 'Up to approximately 51 days (includes from time of screening through study completion including the washout interval)'}]}, 'conditionsModule': {'keywords': ['Healthy Volunteers', 'Bioequivalence', 'Canagliflozin (JNJ-28431754)', 'Metformin IR'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC) tablets of canagliflozin and metformin immediate release (IR) in comparison with the individual components of the FDC tablets (canagliflozin and metformin IR).', 'detailedDescription': 'This is an open-label (identity of study drug will be known to volunteer and study staff), single-center study to evaluate the bioequivalence (to see if blood levels of one drug are equivalent to blood levels of another drug) of canagliflozin and metformin IR when administered orally (by mouth) as individual components (ie, separate tablets of canagliflozin and metformin IR) (Treatment A) and when administered as FDC tablets (ie, canagliflozin and metformin IR contained in the same tablet) (Treatment B). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive a single dose of Treatment A followed by a single dose of Treatment B or Treatment B followed by Treatment A with a washout period of approximately 15 days between treatments. The total duration of the study will be approximately 51 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index (BMI) between 18.5 and 30 kg/m² (inclusive) and a body weight of not less than 50 kg\n\nExclusion Criteria:\n\n* History of or current medical illness, abnormal values for hematology or clinical chemistry laboratory tests, or abnormal physical examination, vital signs or 12-lead ECG deemed to be clinically significant by the Investigator'}, 'identificationModule': {'nctId': 'NCT01508195', 'briefTitle': 'A Study of Canagliflozin and Metformin Immediate Release (50 mg/500 mg) FDC Tablets in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of 2 FDC Tablets of Canagliflozin and Metformin IR (50 mg/500 mg) With Respect to the Individual Components of Canagliflozin (1 x 100 mg) and Metformin IR Tablets (2 x 500 mg) in Healthy Fed Subjects', 'orgStudyIdInfo': {'id': 'CR100684'}, 'secondaryIdInfos': [{'id': '28431754DIA1046', 'type': 'OTHER', 'domain': 'Janssen Research & Development'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence AB', 'description': 'Treatment A (canaglifozin + metformin IR tablets) administered on Day 1 of Treatment Period 1 followed by Treatment B (canagliflozin/metformin IR FDC tablets) administered on Day 1 of Treatment Period 2 with a washout period of 10-15 days between treatment periods.', 'interventionNames': ['Drug: Canagliflozin tablets', 'Drug: Metformin IR tablets', 'Drug: Canagliflozin/metformin IR FDC tablets']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence BA', 'description': 'Treatment B (canagliflozin/metformin IR FDC tablets) administered on Day 1 of Treatment Period 1 followed by Treatment A (canaglifozin + metformin IR tablets) administered on Day 1 of Treatment Period 2 with a washout period of 10-15 days between treatment periods.', 'interventionNames': ['Drug: Canagliflozin/metformin IR FDC tablets', 'Drug: Canagliflozin tablets', 'Drug: Metformin IR tablets']}], 'interventions': [{'name': 'Canagliflozin tablets', 'type': 'DRUG', 'otherNames': ['Treatment A (Reference)'], 'description': 'Type = exact number, unit = mg, number = 100, form = tablet, route = oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period 1.', 'armGroupLabels': ['Treatment Sequence AB']}, {'name': 'Metformin IR tablets', 'type': 'DRUG', 'otherNames': ['Treatment A (Reference)'], 'description': 'Type = exact number, unit = mg, number = 500, form = tablet, route = oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 1.', 'armGroupLabels': ['Treatment Sequence AB']}, {'name': 'Canagliflozin/metformin IR FDC tablets', 'type': 'DRUG', 'otherNames': ['Treatment B (Test)'], 'description': 'Type = exact number, unit = mg, number = 50/500, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 2.', 'armGroupLabels': ['Treatment Sequence AB']}, {'name': 'Canagliflozin/metformin IR FDC tablets', 'type': 'DRUG', 'otherNames': ['Treatment B (Test)'], 'description': 'Type = exact number, unit = mg, number = 50/500, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 1.', 'armGroupLabels': ['Treatment Sequence BA']}, {'name': 'Canagliflozin tablets', 'type': 'DRUG', 'otherNames': ['Treatment A (Reference)'], 'description': 'Type = exact number, unit = mg, number = 100, form = tablet, route = oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period 2.', 'armGroupLabels': ['Treatment Sequence BA']}, {'name': 'Metformin IR tablets', 'type': 'DRUG', 'otherNames': ['Treatment A (Reference)'], 'description': 'Type = exact number, unit = mg, number = 500, form = tablet, route = oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 2.', 'armGroupLabels': ['Treatment Sequence BA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}], 'overallOfficials': [{'name': 'Janssen Research & Development, LLC L.L.C Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Research & Development, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Research & Development, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}